ANSI/AAMI/IEC 62366 calls for manufacturers to implement a rigorous HFE program in conjunction with developing medical devices for which they will seek regulatory approval; an approval that hinges on compliance with IEC standards. However, most legacy medical devices were not developed with a focus on HFE. Consequently, manufacturers are struggling to understand how much HFE is enough when reassessing the use-safety of legacy devices that they have little interest in modifying based on retrospective HFE analyses.

Conducting Usability Tests of Instructions for Use

This webinar will review regulators’ expectations regarding the evaluation and validation of instruction, and will describe effective usability testing approaches that include an evaluation of how well instructions transfer knowledge and skills to users.

Creating Effective Quick Reference Guides

This webinar presents the ubiquitous quick reference guide (QRG) as an unsung hero in the business of guiding users to interact safely and effectively with medical devices. The program discusses how a QRG is often preferred over a full-blown user manual due to being more readily accessible both physically and intellectually. This webinar advocates taking a structured development approach and applying established principles of human factors engineering to produce visually pleasing, legible, and readable content. Learn to review how a good QRG can avert usability problems that could otherwise lead to task failures in a validation usability test and actual medical procedures. Webinar attendees will leave with a new appreciation for the simple, yet effective and economical, QRG.

Designing Safe and Effective Home Healthcare Devices

As medical and combination device manufacturers have learned, sometimes the hard way, the FDA and other regulators expect applications for clearance (e.g., 510(k)) to include strong evidence that home healthcare device users can perform critical tasks safely and effectively. The webinar presenters will summarize the HFE steps required to satisfy regulators.

Designing User-Friendly, Wearable Medical Devices

The number of wearable medical devices is increasing rapidly, powered by component miniaturization, better batteries, sophisticated software, and consumer interest in such devices. The presenters will review the desirable characteristics of wearable medical devices from a human factors engineering perspective, providing tips on designing safe, effective, and satisfying user interfaces.

Developing a Robust Usability Engineering Process

Human Factors is a key component of the product development process. Throughout that process there are critical activities that take place at each phase of the product development life cycle. The webinar will detail out the activities for each process, discuss the advantages of each activity as well as give an overview of how documentation can be key to developing a robust usability engineering process. This session will address the integration of human factors into all phases of product life cycle. It will also give an overview of templates that your company can create for each human factors deliverable, including an outline of what is contained in each of those documents.

Ethnography 101: An Overview of Techniques and Guidelines

This session will provide a high-level overview of ethnography methods; how to plan, screen, and recruit; guidelines on interacting with your users; sample field guide/researchers’ tool kit; and how to prioritize and document the results to help drive design inputs.

Good Design of Medical Device Instructions for Use and Training Materials, Part 1: A Valid Process

The primary purpose of this webinar is to lay out a process for the design of instruction and training materials that is well-integrated with other device design activities and proven to be successful when applied during the pre-market process. A second purpose of the webinar is to elaborate the various types of media available and design considerations relevant to media choices.

Good Design of Medical Device Instructions for Use and Training Materials: A Valid Process

Poorly designed instruction and training materials can be a stumbling block in the pre-market approval process for a medical device, and a cause of adverse events with serious consequences once a device is on the market. Too often, instructions and training receive attention that is too little, and too late, in the design process, The primary purpose of this webinar is to lay out a process for the design of instruction and training materials, based on the recently published guidance in AAMI TIR49:2013, Design of training and instructional materials for medical devices used in non-clinical environments, that is well-integrated with other device design activities, and proven to be successful when applied during the pre-market process.

Horizons 2011 Spring: Improving Medical Alarm Systems

This issue focuses exclusively on improving medical device alarm systems, which warn of danger by alerting caregivers to critical medical information. Today, by and large, medical alarms don’t work well. Too many devices sound too many alarms and are wrong too often. Why is that, and what can be done about it? This special issue examines how to improve the safety and effectiveness of such systems.